<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20260921071145N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-11-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectivenes of schema therapy on appearance anxiety, self-criticism, and body image</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of schema therapy on appearance anxiety, self-criticism, and body image in overweight women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-12-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Pending</recruitment_status>
      <url>https://irct.ir/trial/94179</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, a simple randomization method was employed to assign participants to either the experimental or the control group. The unit of randomization consisted of women with excess weight who met the study's inclusion criteria in the city of Ahvaz. First, a comprehensive list of volunteers who satisfied the inclusion criteria was compiled. Subsequently, each participant was assigned a unique numerical identification code. These codes were entered into a random number generator software, which produced a random number for each individual. Following the generation of these numbers, the participants were sorted in ascending order based on their assigned random values. Participants were then allocated to the two groups: the first 15 individuals on the sorted list were assigned to the experimental group (receiving schema therapy), while the next 15 were assigned to the control group. Through this method, the order in which participants entered the study and the researcher's prior knowledge of the participants played no role in group assignment. To ensure allocation concealment, the individual responsible for data entry and the randomization process was independent of both the intervention administrator and the assessors of the study variables (appearance-related anxiety, self-criticism, and body image); this individual had no insight into the conduct of the sessions and no authority to alter the group assignments. Furthermore, the participants' identification codes were kept confidential and stored separately from their other personal information. Consequently, it was impossible to predict the group assignment for any participant prior to the completion of the randomization process, Blinding description: To adhere to the principles of blinding, the outcome assessor and the data analyst are kept unaware of the allocation of participants to the experimental and control groups. To this end, information regarding participant group allocation will be provided to them in a coded format, and no information concerning the identities or the specific group assignments of the participants will be disclosed to the outcome assessor or the data analyst.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychological problems resulting from being overweight.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Schema therapy consists of ten 45-minute sessions designed to examine self-destructive patterns of thought, emotion, and behavior rooted in childhood. It integrates principles and foundations from cognitive-behavioral, attachment, Gestalt, object relations, constructivist, and psychoanalytic schools of thought. The first session serves as an introduction, covering the program's goals, the number of sessions, ground rules, and the significance of the educational and research framework; research questionnaires are also administered and collected. The second session is dedicated to completing a commitment form, introducing early maladaptive schemas—including how they form and persist—as well as their associated domains and underlying needs. Participants’ specific schemas are categorized, and the application of therapeutic techniques begins. The third session focuses on reviewing previous topics, explaining coping styles, facilitating group discussion, assigning homework, and fostering a dialogue between the hopeful and the hopeless aspects of the mind. In the fourth session, participants develop "healthy" educational cards, utilize the "downward arrow" technique, and review various cognitive techniques. The fifth session involves visualizing a "safe place" and working to transform distressing emotional memories. The sixth session incorporates mindfulness and relaxation techniques, alongside imagined dialogues (mental imagery) with the person or source responsible for the schema. The seventh session centers on writing a letter to the source of the schema, while reinforcing cognitive and experiential techniques. The eighth session focuses on the detailed description and prioritization of coping behaviors. The ninth session covers potential behavioral changes and specific behavioral techniques. In the tenth session, the research questionnaires are once again distributed and completed, questions are addressed, and—following a discussion and synthesis of the entire series of sessions—the intervention is brought to a close. This treatment program, based on the schema therapy approach developed by Young et al. (2012; translated by Hamidpour &amp; Andouz, 2019), was administered to the experimental group over the course of ten 45-minute sessions. Intervention 2: Control group: They do not receive any intervention or treatment.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Participant data is completely confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Lorzanganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Ahvaz, Farhang Shahr.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 903 043 3259</telephone>
        <email>fatemeh.loorzangeneh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Lorzanganeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University of Ahvaz, Farhang Shahr.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6134937333</zip>
        <telephone>+98 903 043 3259</telephone>
        <email>fatemeh.loorzangeneh@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged between 18 and 45 years
Possess at least a high school diploma
Body Mass Index (BMI) above 25
Dissatisfied with their own body image</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Presence of a physical illness that could interfere with the treatment process
Use of psychiatric medications
History of substance abuse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Schema therapy consists of ten 45-minute sessions designed to examine self-destructive patterns of thought, emotion, and behavior rooted in childhood. It integrates principles and foundations from cognitive-behavioral, attachment, Gestalt, object relations, constructivist, and psychoanalytic schools of thought. The first session serves as an introduction, covering the program's goals, the number of sessions, ground rules, and the significance of the educational and research framework; research questionnaires are also administered and collected. The second session is dedicated to completing a commitment form, introducing early maladaptive schemas—including how they form and persist—as well as their associated domains and underlying needs. Participants’ specific schemas are categorized, and the application of therapeutic techniques begins. The third session focuses on reviewing previous topics, explaining coping styles, facilitating group discussion, assigning homework, and fostering a dialogue between the hopeful and the hopeless aspects of the mind. In the fourth session, participants develop "healthy" educational cards, utilize the "downward arrow" technique, and review various cognitive techniques. The fifth session involves visualizing a "safe place" and working to transform distressing emotional memories. The sixth session incorporates mindfulness and relaxation techniques, alongside imagined dialogues (mental imagery) with the person or source responsible for the schema. The seventh session centers on writing a letter to the source of the schema, while reinforcing cognitive and experiential techniques. The eighth session focuses on the detailed description and prioritization of coping behaviors. The ninth session covers potential behavioral changes and specific behavioral techniques. In the tenth session, the research questionnaires are once again distributed and completed, questions are addressed, and—following a discussion and synthesis of the entire series of sessions—the intervention is brought to a close. This treatment program, based on the schema therapy approach developed by Young et al. (2012; translated by Hamidpour &amp; Andouz, 2019), was administered to the experimental group over the course of ten 45-minute sessions.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Manifest Anxiety. Timepoint: Before performing the intervention and two weeks after completion of the intervention. Method of measurement: Vial et al. (2014) Apparent Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Self-criticism. Timepoint: Before performing the intervention and two weeks after completion of the intervention. Method of measurement: Thompson and Zuroff’s (2004) Levels of Self-Criticism Scale.</prim_outcome>
      <prim_outcome>Body Image. Timepoint: Before performing the intervention and two weeks after completion of the intervention. Method of measurement: Ostozin et al.’s (1998) Body Dysmorphic Concern Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-09-11</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz</contact_name>
        <contact_address>Islamic Azad University of Ahvaz, Farhang Shahr Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
